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Study of CLU-RX-BET injection therapy for patients with moderate to severe birch pollen allergies

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on allergic rhinitis and rhinoconjunctivitis caused by birch pollen allergy. These conditions cause symptoms like nasal congestion, runny nose, and eye irritation during birch pollen season. The study will test a medication called CLU-RX-BET, which is given as an injection under the skin to treat birch pollen allergies. The purpose is to find the most effective and best-tolerated dose of this treatment.

The study will compare three different doses of CLU-RX-BET (high, medium, and low) against a placebo. The treatment will be given through subcutaneous injections, which means the medication is injected beneath the skin. The study medication contains modified birch pollen extract that has been treated with a substance called glutaraldehyde to make it safer for treatment.

During the study, participants will receive multiple injections over a period of 50 weeks. They will need to track their allergy symptoms and use of additional medications during the birch pollen season. The effectiveness of the treatment will be measured by monitoring how well it reduces allergy symptoms and the need for other allergy medications compared to the placebo treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive subcutaneous injections (under the skin) of either CLU-RX-BET (in low, medium, or high dose) or a placebo solution

    The placebo solution looks, smells, and tastes identical to the active treatment but contains no active ingredients

    The treatment is specifically designed for birch pollen allergy

  2. Step 2

    Monitoring during birch pollen season

    You will need to complete an electronic diary to record your allergy symptoms and any additional medications used

    The monitoring will focus on both nasal symptoms (affecting the nose) and ocular symptoms (affecting the eyes)

    Your symptoms will be tracked during the peak birch pollen period and throughout the entire birch pollen season

  3. Step 3

    Quality of life assessment

    You will complete a quality of life questionnaire focused on how allergies affect your daily activities

    You will rate your overall discomfort from allergies using a visual scale from 0 to 10

  4. Step 4

    Nasal provocation testing

    You will undergo a nasal provocation test where your nose's reaction to birch pollen is measured

    This test will be performed before and after the treatment period to measure any changes in your allergic response

  5. Step 5

    Safety monitoring

    Any side effects or reactions to the treatment will be recorded and monitored

    Regular safety assessments will be conducted throughout the study period

Who can join the trial?

12 criteria

  • Must sign and date the informed consent form before any study examinations
  • Age must be between 18 and 65 years when signing the consent form
  • Must have had moderate-to-severe allergic rhinitis or rhinoconjunctivitis (allergic reactions affecting nose and eyes) caused by birch pollen for at least 2 years
  • If asthmatic, must have well-controlled mild-to-moderate asthma. Non-asthmatic individuals may also participate
  • For asthmatic patients: must have FEV1 (amount of air that can be forcefully exhaled in one second) greater than 80% of normal predicted value
  • Must show allergic reaction to birch pollen confirmed by:
    • Positive skin prick test
    • Specific blood test showing birch pollen allergy
    • History of significant allergy symptoms during birch pollen season
    • Positive response to nasal exposure test with birch pollen
    • Must be able to understand and follow instructions for using electronic diary
    • Must be willing and able to complete daily electronic diary entries about symptoms and medication use
    • Must have normal laboratory test results, or results that doctors consider not medically concerning

Who cannot join the trial?

12 criteria

  • History of severe allergic reactions (anaphylaxis) to any allergen
  • Previous treatment with immunotherapy (allergy shots or tablets) for birch pollen in the past 5 years
  • Current asthma that is not well controlled with medication
  • Presence of other significant respiratory conditions that could interfere with the study results
  • Ongoing treatment with medications that could affect allergy symptoms or interact with the study medication
  • Pregnancy or planning to become pregnant during the study period
  • Participation in another clinical trial within the past 30 days
  • History of autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Serious medical conditions that could compromise safety during the study
  • Known allergies or sensitivity to any components of the study medication
  • Use of systemic corticosteroids (oral or injectable anti-inflammatory medications) in the past 3 months
  • Inability to follow study procedures or attend scheduled visits
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Investigated drugs

CLU-RX-BET is an immunotherapy treatment designed to help patients who are allergic to birch pollen. It is administered under the skin (subcutaneously) and works by gradually exposing the patient to small amounts of birch pollen allergens. This helps the immune system become less sensitive to birch pollen, potentially reducing allergic symptoms and the need for other allergy medications. This type of treatment is known as cluster immunotherapy, which means that multiple doses are given in a clustered schedule to build up tolerance more quickly than traditional immunotherapy.

What is already known about the treatment

CLU-RX-BET – A subcutaneous immunotherapy medication designed for treating moderate to severe allergic rhinitis and rhinoconjunctivitis caused by birch pollen allergies. This investigational treatment is administered through subcutaneous injections using a cluster immunotherapy protocol, which aims to build tolerance to birch pollen allergens. The medication works by modifying the immune system's response to birch pollen, gradually reducing allergic reactions and symptoms. As a specific immunotherapy product, it belongs to the class of allergy desensitization treatments, currently being evaluated in Phase II-III clinical trials to determine its optimal dosing and safety profile.

Investigated diseases

  • Allergic rhinitis

    A condition where the immune system reacts to airborne substances like pollen, causing inflammation of the nasal passages. The condition causes symptoms such as sneezing, runny nose, nasal congestion, and itchy nose, often accompanied by eye symptoms like watery and itchy eyes. Allergic rhinitis can be seasonal (triggered by specific pollen seasons) or perennial (occurring year-round). When birch pollen triggers the condition, symptoms typically appear during the birch pollination period in spring.

  • Allergic rhinoconjunctivitis

    A combination of allergic reactions affecting both the nasal passages and eyes. The condition occurs when allergens like pollen trigger an immune response, causing inflammation of the nasal mucosa and conjunctiva (the membrane covering the eye). Symptoms include nasal congestion, sneezing, and runny nose, along with red, itchy, and watery eyes. The condition commonly occurs during specific pollen seasons, with birch pollen being a frequent trigger in spring.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-517515-75-00Protocol codeSC-3F2AEstimated enrolment700 patientsSponsorROXALL Medizin GmbH

sourced from the EU Clinical Trials Register and site verification

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